CD Horizon® Spinal System - SCREW 55740007085 5.5/6 MAS 7.0X85 CC S - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: SCREW 55740007085 5.5/6 MAS 7.0X85 CC S

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More Product Details

Catalog Number

-

Brand Name

CD Horizon® Spinal System

Version/Model Number

55740007085

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202328

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

eb163f37-acda-4049-a31e-9af8fd86f7b3

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75